FDA Approves Ingestible Sensor That Transmits Patient Data To Doctors

CBS News — Take these with water: Digestible sensors that can report medication adherence and vital signs have been approved by the U.S. Food and Drug Administration (FDA).

Proteus Digital Health, Inc. announced that the FDA has approved their product, the Ingestion Event Marker (IEM). The ingestible sensor, which was already been approved for use in Europe in 2011, can transmit information about the patient to medical professionals and help them customize care.

“We are thrilled to have achieved this important milestone to market our ingestible sensor in the United States now, as well as in Europe,” Dr. George M. Savage, co-founder and chief medical officer at Proteus Digital Health. “We are very much looking forward to bringing the benefits of our ingestible sensor to the American public in the form of innovative product offerings.”

The sensor, which is the size of a grain of sand, can be put inside a pill or other consumables and is powered by stomach fluid. Once swallowed, the device transmits a signal to a patch on the user’s stomach that can determine when the item was consumed, as well as other physiological and behavioral metrics including heart rate, body position and activity. Then the information can be sent to a mobile phone app to the patient and, with the patient’s permission, their medical caregivers.

Savage adds that the point of the sensor is not to watch over patients like a hawk, but to help doctors adjust medications and treatments if necessary. “This way doctors can prescribe a different dose or a different medicine if they learn that it’s not being taken appropriately.”

Some doctors feel that the device will be able to help with medicine adherence, in other words getting people to continue taking their medication. “About half of all people don’t take medications like they’re supposed to,” says Eric Topol, director of the Scripps Translational Science Institute in La Jolla, California. “This device could be a solution to that problem, so that doctors can know when to rev up a patient’s medication adherence.”

The company has not disclosed how much the device will cost. It says it will depend on the context in which the system is being used.